tbuckley/cabot-search huggingface dataset:
A randomized phase III clinical trial of yoga for chemotherapy-induced peripheral neuropathy treatment.
Authors: Kirin Saint, Katherine Han, Lauren Piulson, Christina Seluzicki, Iris Zhi, Ting Bao
Journal: Journal of Clinical Oncology (2023)

TPS12143 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, painful, and debilitating side effect of many standard chemotherapy regimens. CIPN symptoms include pain, paresthesia, and muscle weakness, and patients may exhibit functional decline and lower quality of life. Our prior study showed more than half of breast cancer survivors experience persistent CIPN up to a mean duration of 5.6 years, which is associated with a doubled fall risk. Identifying non-pharmacological approaches to reduce CIPN symptoms and improve cancer survivors’ outcomes is urgently needed. Yoga is a meditative movement therapy that includes stretching, and flexibility and balance training. Our pilot study (NCT03292328) demonstrated that yoga reduced CIPN-related symptoms, and improved quality of life and functional reach scores compared to waitlist control. We hypothesize that yoga can reduce CIPN symptoms, improve function, and reduce the risk of falls. Methods: We are conducting a three-arm randomized education and usual care-controlled trial in cancer survivors with chronic CIPN pain at Memorial Sloan Kettering Cancer Center (MSK), New York, NY. Participants in the intervention arm will receive twice-weekly one-hour Hatha yoga classes taught virtually by MSK instructors and practice yoga at home daily for eight weeks. Participants in the education control arm will receive one-hour virtual education classes twice per week taught by an MSK instructor for eight weeks. Participants in the usual care arm will continue their usual care for CIPN for eight weeks. The primary endpoint is the Brief Pain Inventory-Short Form average pain item at weeks 8 and 24. Secondary outcomes include the Neuropathic Pain Scale, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, Patient-Reported Outcomes Measurement Information System Global Health, Brief Fatigue Inventory, Insomnia Severity Index, Hospital Anxiety and Depression Scale, Quality of Life Questionnaire of CIPN twenty-item scale, functional assessments, and quantitative sensory testing at weeks 0, 4, 8, 12, 18, and 24. Eligibility criteria include: 1) Moderate-to-severe CIPN pain, defined by a score of 4 or greater on a 0-10 numerical rating scale; 2) completion of neurotoxic chemotherapy at least three months prior; 3) no changes in anti-neuropathy medications within three months of enrollment; and 4) changes in balance and functionality. As of February 2023, we have accrued 64 of our total target of 268 participants. We anticipate completing accrual in March 2025. We have 35 participants in the yoga intervention, 15 participants in education control, and 14 participants in usual care control. The majority (89%) of participants are female and 11% are male. 78% of our participants are white, 16% are black or African American, 1% are Asian, and 5% identify as more than one race. Clinical trial information: NCT05121558 .
Dissecting the prognostic role of baseline body mass index (BMI) in early breast cancer (BC): Individual patient-level analysis from five mammella interGruppo (MIG) and gruppo italiano mammella (GIM) randomized clinical trials (RCTs).
Authors: Davide Soldato, Eva Blondeaux, Marco Bruzzone, Silvia Mura, Michelino De Laurentiis, Anna Turletti, Sabino De Placido, Giancarlo Bisagni, Anita Rimanti, Andrea Michelotti, Alessandra Fabi, Antonio Russo, Stefania Gori, Antonio Durando, Guilherme Nader Marta, Evandro de Azambuja, Antonio Di Meglio, Ines Vaz-Luis, Matteo Lambertini, Lucia Del Mastro
Journal: Journal of Clinical Oncology (2023)

12067 Background: Nearly half of patients (pts) are overweight or obese at BC diagnosis (dx). Higher BMI at dx has been associated with cardiometabolic comorbidities, higher risk of severe treatment-related sequelae, and worse quality of life. Previous studies showed inferior survival outcomes among patients with early BC and high BMI, although not consistently. The aim of this study was to explore the prognostic role of BMI at dx using data from five RCTs of adjuvant therapy for early stage BC with long-term follow-up. Methods: Pts with known BMI at dx, randomized in the MIG-1, MIG-5, GIM-2, GIM-3 and GIM-6 phase III RCTs were included. BMI was categorized as lean ( &lt; 25 kg/m2), overweight (25-30 kg/m2) or obese (≥ 30 kg/m2). Outcomes included disease-free survival (DFS), breast cancer free-interval (BCFI) and overall survival (OS). Survival estimates were compared using the Kaplan-Meier method and log-rank test. Multivariable Cox proportional hazard models stratified by trial and relevant prognostic factors assessed associations between BMI and outcomes. Results: Among 7334 pts in the overall population, mean age was 56.4 years (SD 11.2), 67.8% had node-positive disease, 76.9% received chemotherapy and 83.0% endocrine therapy. Most pts were overweight (33.1%) or obese (21.0%) and 45.9% were lean. Higher BMI was associated with older age, larger tumor size, higher nodal status, and HR+/HER2- subtype. At a median follow-up of 10.0 years (IQR 6.1-15.1) there were 2165 DFS, 1674 BCFI and 1354 OS events. Pts with higher BMI had worse DFS and OS (log-rank p = 0.007 and p &lt; .0001, respectively), but similar BCFI (p = 0.48). BMI at dx was an independent risk factor for worse OS, but not for DFS and BCFI (Table). Results in the HR+/HER2- population (n = 4093) were consistent: pts with higher BMI had worse DFS, BCFI, and OS (log-rank p = 0.001, p &lt; .006, and p &lt; .0001, respectively) and BMI at dx was an independent risk factor only for worse OS (aHR [95%CI] 1.06 [0.84-1.32] and 1.31 [1.02-1.67] for overweight and obese vs lean pts, respectively). Conclusions: In this large study of pts with early BC treated in RCTs with long-term follow-up, higher BMI at dx was an independent risk factor for overall mortality but not for BC-specific outcomes. Weight loss interventions may mitigate the detrimental effect of excess body weight on outcomes of BC survivors, including by reducing the burden and risks of associated cardiometabolic comorbidities. [Table: see text]
A retrospective study of Merkel cell carcinoma treated at The Ohio State University (OSU) in the last 20 years.
Authors: Chunjie Li, Kari Lynn Kendra, Carlo M. Contreras, Dukagjin Blakaj, Richard Cheng Han Wu, Claire F. Verschraegen
Journal: Journal of Clinical Oncology (2023)

e21586 Background: Merkel cell carcinoma (MCC) is a rare but aggressive neuroendocrine cutaneous malignancy. The analysis of interventions and benefits of treatments remain limited. In this retrospective study, we analyzed the clinical features and outcomes of MCC patients treated at the OSU Comprehensive Cancer Center (OSUCCC). Methods: Electronic medical records of MCC patients who were treated from 2000 to 2021 at OSUCCC were reviewed. 179 patients were enrolled. 153 patients were analyzed for overall survival (OS) after excluding 26 patients due to loss of follow-up or insufficient data. Clinical features were collected. The first patient was treated with immunotherapy (IO) on 2/24/2015. The period after this date was defined as the IO era (87 patients). Results: Among 179 patients (median age 73, male 64.8%), 41.9% died, 13.4% were lost to follow-up and 44.7% were alive by 12/31/2022. Primary tumor locations were head (50.8%), upper &amp; lower extremities (21.2% &amp; 10.6%), unknown primary (6.1%), trunk (5%) and neck (4.5%). Patients with stage I, II, III and IV were 41.9%, 12.8%, 36.9% and 8.4%, respectively. Sentinel lymph node biopsy (SLNB) was performed in 73.8% of patients; tumor involvement in SNL was confirmed in 38.5% and SLNB attempts failed in 15.1%. Patients who received surgery, local radiation, IO, chemotherapy and targeted medication were 92.7%, 66.5%, 27.4%, 10.1% and 2.8%, respectively. All 75 stage I patients had wide excision, and 50.7% received local radiation. 12% of stage I patients developed tumor recurrence, with IO administered in 55.6% of those patients. Most patients with stage II (52.2%) and stage III (34.8%) received surgery followed by radiation. 20% of patients with stage IV received surgery followed by radiation and IO. The median OS was 95 months (95% CI 67-123), the 3-year survival rate was 70%, and the 5-year survival rate was 61% for the 153 assessable patients. The median OS in stage I, II, III and IV was 149, not reached, 65 and 20 months, respectively ( P&lt; 0.05). Survival in tumors on the head/neck was similar to the upper and lower extremities (median OS 102 vs. 71 vs. 99 months, P&gt; 0.05) but slightly superior to the trunk disease (median OS 102 vs. 15 months, P= 0.072). The outcome of never-smokers was superior to former smokers (median OS 156 vs. 71 months, P&lt; 0.01). The median OS of stage IV patients with IO was superior to those without IO (95 vs. 10 months, P&lt; 0.05). Among dead patients in the IO era, the median OS of patients with IO was longer than those without IO (22 vs. 6 months, P&lt; 0.01). Conclusions: Most MCC occur in the elderly, local or regional disease, and commonly on the head with a good outcome after multidisciplinary therapies. Former smokers and stage IV disease relate to a poorer prognosis. IO shows benefits with prolonged survival, especially in metastatic disease.
Role of adjuvant chemotherapy (CT) in node negative 4-5 cm non-small cell lung cancer in elderly population.
Authors: Suman Gaire, Pravash Budhathoki, Anish Kumar Shah, Ranjit Jasaraj, Dipesh Uprety
Journal: Journal of Clinical Oncology (2023)

e20615 Background: The role of adjuvant CT for 4-5 cm primary lung tumors without any regional lymph node involvement following surgical resection is somewhat controversial. While it is favored in most cases, it should be individualized depending on other pathological risk factors and the patient's performance status. In this study, we investigated the benefit of adjuvant CT in elderly patients with 4-5 cm tumor size following complete surgical resection. Methods: We utilized Surveillance, Epidemiology, and End Results Program (SEER) database to identify elderly patients (≥65 years) with 4 to 5 cm sized non-small cell lung cancer after complete surgical resection diagnosed from 2010-2015. The baseline characteristics among the patients who received and didn’t receive adjuvant CT were compared using relevant parametric/non-parametric tests. Kaplan Meir curve was generated for the univariate survival analysis, and the log-rank test was used for comparison. Multivariate survival analysis was done using the cox proportional hazards regression model. Results: The database included 2582 patients. Among them, 492 (19.1%) cases had received adjuvant chemotherapy while 2090 (80.9%) cases had not. The population that received chemotherapy was younger than those that did not (Median:75 years vs 71 years, p &lt; 0.001). The 5-year overall survival for patients who received chemotherapy was significantly higher than those who did not (53.9% vs 46.5%, P = 0.002). On the multivariate analysis adjusted for age, gender, race, income status, and type of surgery, cases with adjuvant chemotherapy had lower hazards as compared to those who had not received adjuvant chemo (Hazard Ratio (HR):0.86, confidence interval (CI): [0.75,0.99], P value = 0.04). Conclusions: Our study demonstrated a survival benefit with adjuvant CT for node-negative NSCLC of 4-5 cm size in the elderly population.
Outcomes of 10-day decitabine with venetoclax for AML.
Authors: Alexander Coltoff, Praneeth Baratam, Kimberly Michelle Green, James A. Davis, Deidra Smith, Kelly Gaffney, Elizabeth Dougherty, Laura Milligan
Journal: Journal of Clinical Oncology (2023)

7022 Background: Venetoclax (VEN) + a hypomethylating agent (HMA) has improved outcomes for patients with acute myeloid leukemia (AML). VIALE-A showed improved overall response rate (ORR) and overall survival (OS) with VEN + HMA in newly diagnosed AML (ND AML); the complete remission (CR) rate was 36.7% and the median OS was 14.7 months. Later, DiNardo et al. reported a trial of 10-day decitabine (DEC10) + VEN with a CR rate of 65.7% and a median OS of 18 months in a ND AML cohort. We report real world outcomes of VEN + DEC10 for AML induction. Methods: We reviewed 82 adult patients treated with VEN + DEC10 at our institution. Patients received 1 or 2 cycles of VEN + DEC10 followed by additional cycles of VEN + 5-day decitabine (DEC5) per physician discretion. Results: Twenty-four patients had ND AML, 28 had secondary AML (sAML) and 30 had relapsed/refractory (R/R AML) with a median age (years) of 72, 70, and 59 in each group, respectively. Cytogenetics were poor-risk in 13 ND patients (54.2%), 14 sAML patients (50%), and 17 R/R patients (56.7%). Twenty-two patients (26.8%) had TP53 mutations. Six patients (7.3%) received rasburicase. Neutropenic fever was seen in 46 patients (56.1%), and 34 (41.5%) had documented infections. Thirty-eight patients (46.3%) were re-hospitalized during cycle 1 (C1), at a median of 22 days after starting. The median time from the start of C1 to C2 was 41 days. Thirty-day mortality was 7.3%. In ND AML, ORR was 91.7% and composite CR rate (CRc; CR + CR with incomplete hematologic recovery[CRi]) was 75%. Nine of 15 patients (60%) in CR were negative for measurable residual disease (MRD-). In sAML, ORR was 53.6% and CRc rate was 50% (35.7% MRD- CR). CRc was achieved by eight of 16 (50%) untreated sAML patients vs six of 12 (50%) who were previously treated. In R/R AML, ORR was 56.7% and CRc rate was 43.3% (53.8% MRD- CR). TP53-mutated AML had an ORR of 59% and a CRc of 50%. Median OS was 5.5 months in TP53-mutant AML, 7.4 months in R/R AML, and was not reached in ND AML or sAML. Fifteen patients (18.3%) received an allogeneic transplant (3 ND, 3 sAML and 9 R/R) in MRD- CR (n = 11), MRD+ CR (n = 2) and CRi (n = 2). At a median of 263 days post-transplant, there were 3 relapses and the median OS was not reached. Conclusions: VEN + DEC10 compared favorably with published data, yielding high ORR, CR, and MRD- CR rates in ND AML. CR rate for R/R AML with VEN + DAC10 was similar to that for ND AML in the VIALE-A trial. These results warrant a prospective, randomized trial of VEN + DEC10 vs VEN + DEC5 in AML. [Table: see text]
Establishment of a nomogram predictive model for survival and prognosis of 97 patients with different subtypes of lung adenocarcinoma after radical resection.
Authors: Aliya Aosiman, Patiguli Aerxiding, Gulinuer Nuermaimaiti, Yang Zheng, Yuan Meng
Journal: Journal of Clinical Oncology (2023)

e20596 Background: Postoperative recurrence and metastasis of lung adenocarcinoma (LUAD) is a major obstacle to long-term survival, and how to identify patients at high risk of recurrence / death after surgery and those likely to benefit from adjuvant therapy is currently a clinically relevant question. In this study, we investigated the survival characteristics of patients with different subtypes of LUAD after radical resection and established predictive prognostic models to inform postoperative management, recurrence prediction and risk management in lung cancer patients. Methods: A retrospective analysis of 97 patients who underwent concurrent genetic testing for LUAD radical resection at The Affiliated Tumor Hospital of Xinjiang Medical University between December 01, 2014 and December 30, 2017 was performed. A COX proportional risk regression model was used to construct a prognosis model for patients with LUAD after surgery and visualization of the model was performed using column diagrams. The performance of the model was evaluated using C index, calibration curve, and ROC curve. Results: (1)46 patients (47.42%) were included and 51 patients died (52.58%), with a median survival of 78 months (95% CI: 63-93). Twenty of these patients had a good prognosis (20.62%) and 77 had a poor prognosis (79.38%), with a median survival time of 88 months (95% CI: 81-95). The overall survival rate was 98.9%, 78.3% and 59.7%, respectively, and the cumulative disease-free survival rate was 77.3%, 37.1% and 20.6%, respectively, for 1, 3 and 5 years. Pathologic types were lepidic, acina/papillaryand solid/micropapillary with 87.50%, 56.90% and 58.80% OS and DFS, respectively. 37.50%、80%、11.80%. (2)26 patients (26.8%)had recurrent metastasis,the main site of metastasis was extrapulmonary, and multiple metastases were more common. (3)Univariateand multivariate analysis showed that TNM stage III, pathological classification as solid/micropapillary, tumor diameter ≥ 3cm, and gene mutation positivity were independent risk factors for prognosis in patients with lung adenocarcinoma after surgery. Based on the above risk factors, the Nomogram prognostic model was established with a C index of 0.687 (95% CI: 0.622-0.752) and calibration curves and ROCs for the 1, 3, and 5 year models, respectively, with AUC values of 0.742, 0.752, and 0.820 &gt; 0.7, suggesting that the model is within the acceptable range of partitioning and accuracy, with the highest AUC for the 5-year DFS prediction. Conclusions: High TNM staging, pathotyping of micronipples or entities, ≥ 3cm tumor diameter, and mutant positivity were independent risk factors for recurrence and metastasis in patients with LUAD. The Nomogram predictive model based on patient risk factors after LUAD radical resection is effective in predicting long-term survival and guiding personalized treatment.
Trends and factors related to pregnancy after breast cancer treatment in young patients.
Authors: Young-Jin Lee, Young Joo Lee, Tae-Kyung Yoo, Sae Byul Lee, Jisun Kim, Il Yong Chung, Beom Seok Ko, jong Won Lee, Byung Ho Sohn, hee Jeong Kim
Journal: Journal of Clinical Oncology (2023)

e24095 Background: In women of reproductive age who have been treated for breast cancer (BC), interest in fertility preservation (FP) is as important as treatment. Although methods for FP are already well known, sufficient information is not provided about the pregnancy results at specified BC stage or treatment. This study was designed to retrospectively analyze and provide information on fertility preservation attempts and actual pregnancy in women of childbearing age who had been diagnosed with BC for the past 10 years. Methods: We retrospectively reviewed women of childbearing age (18-40 years) with treated at single tertiary medical center from December 2010 to September 2020. The relationship between the tumor characteristics and treatments and actual pregnancy was analyzed. Time from diagnosis to pregnancy was analyzed according to tumor characteristics and treatments. During the period, intensive education on FP was offered to the patients from 2014, and whether there were any changes in the results before and after this was also analyzed. Results: A total of 1033 patients were included, representing 115 patients who were pregnant during the observation period. Overall, 519 (50.2%) patients were offered fertility counseling, 81 (7.8%) patients get oocytes or embryos preservation and 456 (44.1%) patients underwent Gonadotrophin hormone receptor analogue (GnRHa) for FP. Our analysis showed differences in pregnancy rates for age at diagnosis ( P= .002), HR (Hormone receptor) status ( P=.015), and hormonal therapy ( P= .004), among them, there was a significant difference in pregnancy timing only for HR (2.53 vs 3.42 years, P= .009) and hormonal therapy (2.39 vs 3.56 years, P&lt;.001). There were 93 patients who stopped taking tamoxifen for preparing pregnancy, and 53 patients succeeded in becoming pregnant. In this cohort there were no significant difference in pregnancy rate for age, tumor characteristics, stage and treatments. Conclusions: Tumor characteristics which required endocrine therapy was related to the pregnancy rate and time to conception. However, more than half of the women who actively consulted with their doctor for pregnancy and interrupted endocrine therapy within first five years had a successful pregnancy and also were not inferior in disease free survival. Most of FP was still predominantly underwent with concurrent GnRHa use. In young women who want to preserve fertility, it is important to provide such information and make mutual decisions for active FP.[Table: see text]
High risk neuroblastoma (HR-NB) with MNA and age &lt;18 months: Results from the HR-NBL1/SIOPEN trial.
Authors: Ruth Lydia Ladenstein, Ulrike Poetschger, Dominique Valteau Couanet, Shifra Ash, Maja Beck Popovic, Walentyna Balwierz, Tom Boterberg, Godfrey Chi-Fung Chan, Martin Elliott, Per Kogner, Holger N. Lode, Genevieve Laureys, Roberto Luksch, Josef Malis, Cormac Owens, Vassilios Papadakis, Sabine Sarnacki, Sabine Taschner-Mandl, Gudrun Schleiermacher, Adela Canete
Journal: Journal of Clinical Oncology (2023)

10000 Background: The INES 99.4 trial (JCO 2009,27(7):1014-9) for MYCN amplified (MNA) infants using 6 courses of CBDCA-Vp16/CADO showed early progressions or non-response in 30%. Two-year overall survival (OS) was 30% (SE, 0.08) with median survival of 12 months. Aims are to report risk factors and outcomes for patients &lt; 18 months with MNA neuroblastoma treated on HR-NBL1/SIOPEN. Methods: From 2006-2022, patients &lt; 18 months with MNA INSS stages &gt; 1 were eligible. All infants received Rapid Cojec induction, eventually 2 TVDs, Busulfan-Melphalan as high-dose treatment and could receive Dinutuximab- beta immunotherapy. Toddlers (12-18 months) followed the HR-NBL1/SIOPEN respective eligibility criteria. Results: Median age at diagnosis was 1.2 years in 414 patients (median follow up 7 years): 56% were male; 18.6% had localised tumours, 6.8% stage 4S and 75% stage 4. The predominant primary tumour site was abdominal (85%). Rapid Cojec was used in 85%, BUMEL in 89% and 26% received Dinutuximab-beta. Multiple metastatic compartments were reported in 82% of stage 4. Five-year event-free (5y-EFS) and overall survival (5y-OS) was 0.46±0.03 and 0.51±0.03. Stage 2,3&amp;4S patients had a better 5y-EFS of 0.64±0.03 (p &lt; 0.005) (5y-OS:0.66±0.06), compared to stage 4 with 0.41±0.03 (OS:0.46±0.03). Infants’ 5y-EFS was superior with 0.53±0.04 (5y-OS:0.57±0.04) (p = 0.015) over the toddlers with 5y-EFS 0.42±0.03 (5y-OS:0.46±0.03). Patients with bone marrow (BM) and skeletal metastases ± other sites (MS) did worse (p &lt; 0.005) with a 5y-EFS of 0.31±0.04 (5y-OS:0.36±0.04) whilst other metastatic combinations revealed outcomes above 0.50 ±0.03. LDH (2x &gt; normal) predicted a worse 5y-EFS of 0.43±0.03 (5y-OS:0.46±0.03) (p &lt; 0.001) versus normal LDH (5y-EFS 0.71±0.07; 5y-OS:0.80±0.06). EFS multivariable analysis at diagnosis (MVA) showed independent significance for stage 4 (p-value 0.0139; HR: 1.608) and LDH (p-value 0.0042; HR: 2,237), but not for age. In stage 4 patients MVA on EFS found LDH (p-value 0.0098; HR: 2,567) and BM/skeleton involvement (p-value 0.0024; HR: 1,693) as independent risk predictors. In maintenance Dinutuximab-beta had a major impact on 5y-EFS in stage 4 patients with 0.69±0.05(5y-OS:0.71±0.05) vs. 0.41±0-07 (0.46±0.07) for those treated with 13-cis retinoic acid (p = 0.002 &amp; p = 0.001), but not on others. Conclusions: In HR-NBL1/SIOPEN outcomes improved with almost half of patients alive at 5 years and only few late events. Clinical trial information: NCT01704716 .